Kornimate/medical-research-clean huggingface dataset:
a study of 1018 immunostimulatory sequence (iss) administered with irinotecan and cetuximab to treat patients with previously treated metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the main objectives of this study are to establish a safe, tolerable and active dose of 1018 iss administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer. other objectives also include determining tumor response, time to disease progression, and overall survival in treated patients.

this is a phase i, open-label study of escalating dose levels of 1018 iss in combination with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer. approximately 15 patients will be treated. the objectives of this study are to establish a safe, tolerable, and active dose of 1018 iss, determine tumor response, time to disease progression, and overall survival in treated patients. the safety and tolerability of 1018 iss will be evaluated by periodic laboratory assessments, physical examinations, and compilation of adverse events. once study patients have been consented, screened, and assigned to one of the dose levels of 1018 iss, patients will receive two 4 week cycles of 1018 iss therapy plus irinotecan every other week and cetuximab weekly. irinotecan and cetuximab will continue thereafter until disease progression, unacceptable toxicity, or until the patient refuses treatment.

Eligibility criteria:
inclusion criteria: * signed, written, informed consent must be obtained from the patient or their legal representative before any study-specific procedures are performed * confirmed diagnosis of adenocarcinoma of the colon or rectum not amenable to curative surgery * one or more prior systemic therapy regimens for metastatic cancer which must have included a fluoropyrimidine (5-fluorouracil (fu) by infusion or capecitabine), oxaliplatin or irinotecan with or without bevacizumab exclusion criteria: * clinically significant obstructive symptoms, intestinal bleeding, or chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom * history of unstable or deteriorating cardiovascular or cerebrovascular disease within 3 months before the first dose of protocol therapy * clinical evidence of brain metastases or central nervous system disease * pregnant or lactating women * serious medical or psychiatric illness * malignancy other than colorectal carcinoma within the past 2 years, except curatively treated, superficial skin cancer or carcinoma in situ of the cervix * patients who have been on any experimental study or anti-tumor therapy, received radiotherapy, or had prior surgery (except venous access device placement) within 28 days before the first dose of protocol therapy

Keywords: colorectal cancer carcinoma metastatic colon rectal neoplasm cetuximab irinotecan 1018 iss combination therapy
performance evaluation of a non-invasive glucose monitor as compared to cgm data acquired by the ipro2

Conditions: Type 1 Diabetes

Summary: this study is for adults and adolescents with type 1 diabetes. the purpose of this study is to learn more about an investigational system to measure blood glucose. this system does not require blood to be drawn from the body, and it does not require a glucose sensor to be worn under the skin (subcutaneously). this device instead estimates blood glucose levels by shining infrared light on the skin and then using sophisticated statistical analysis on how the light bounces back or gets absorbed (spectral data). the researchers in this study will compare the accuracy of the new device to glucose measurement devices that are already approved by the fda, including glucose meters and subcutaneous continuous glucose monitoring (cgm) sensors. information learned from this study will be used in the development of tools for managing diabetes.

the purpose of the study is to evaluate the utility of a novel approach to non-invasive glucose sensing. the testing for each patient includes fingerstick and alternate site capillary blood measurements taken nearly simultaneously with a series of near-infrared spectra collected via a novel, proprietary fiber-optic probe. simultaneously, subjects will be wearing a commercial continuous glucose measuring system (medtronic ipro 2). the spectral data are converted to a prediction of tissue glucose using a proprietary pre-defined universal algorithm. subjects are tested every 20 minutes for up to 12 hours per day and up to 6 visits per patient over a period of up to 4 months.

Eligibility criteria:
inclusion criteria: * are between the ages of 12-75 years * have been diagnosed with type 1 diabetes mellitus * use insulin to treat your diabetes * agree and are able to follow the study plans as described in this informed consent form. exclusion criteria: * are a pregnant woman or nursing mother * have skin conditions that could cause a problem wearing a glucose sensor on your abdomen (stomach area) and/or having spectral data measured from your forearm with the non-invasive device. * are currently taking part in another clinical study * have taken part in this study before * have experienced severe hypoglycemia (an episode of low blood sugar that you were unable to treat yourself - e.g., seizure, coma, unconsciousness) any time within the past six months * have any additional condition(s) that in the investigator's opinion would warrant exclusion from the study or prevent you from completing the study

Keywords: diabetes type 1 continuous glucose monitor
patient experiences on the stroke unit

Conditions: Ischemic Stroke

Summary: in this study we want to develop and validate a prem for patient with ischemic stroke.

patient reported experience measures (prems) assess patient's perception of health care. currently, there is no suitable prem tool for patients with ischemic stroke. therefore, we aim to develop and validate a prem for this patient population. this prem will be validated in a multicentre study, in 10 flemish hospitals. we want to investigate the feasibility of our new questionnaire, as well as the usefulness. in addition we well analyse the results of the questionnaires and use this information to improve the quality of the care program for stroke patients.

Eligibility criteria:
inclusion criteria: * \> 18 years * ischemic stroke * stayed at least one day at the stroke unit exclusion criteria: * not able to read the questionnaire * not able to answer question orally * are not proficient in the dutch language
evaluating piezo-icsi. - the epi study.

Conditions: IVF; Infertility

Summary: intracytoplasmic sperm injection (icsi) has successfully been used to treat both severe male infertility and fertilization failure since its introduction in the early 1990´s. during the procedure a single sperm is injected into the cytoplasm of an oocyte to achieve fertilization. this technique is intrusive, has a relatively long learning curve and variable operator performance. a new injection technique called piezo-icsi has recently been introduced. during piezo-icsi, a piezo-electric effect is generated through the conversion of electric energy to mechanical energy. this causes a smooth movement of the injection pipette, which allows for steady, controlled microinjections with less psychical stress applied on the oocytes than by the conventional technique. a recent analysis, based on data from 9 different studies comparing conventional icsi and piezo-icsi (17500 cases), showed a benefit of piezo. unfortunately, proper randomized trials are missing from this analysis. the proposed study is a randomized controlled study carried out at two private ivf clinics. eligible participants are patients undergoing icsi treatment, with a minimum of 6 oocytes. the participants will act as their own controls, with their oocytes randomly and equally divided between injection by the investigated and the conventional technique. whether piezo-icsi is associated with improved success rates or reduction in adverse outcomes is at present unclear. patients with fragile oocytes may benefit more from piezo-icsi. in patients above 35 years, piezo-icsi has been associated with a lower oocyte degeneration rate and an increased blastocyst rate. the aim of the study is to investigate whether the piezo-icsi technique will result in more oocytes becoming normally fertilized compared to conventional icsi. another proposed benefit of piezo-icsi lies in the standardization and simplification of the icsi procedure. making the injection procedure more independent of operator skill may result in a more robust and predictable laboratory output.


Eligibility criteria:
inclusion criteria: 1. patients receiving controlled ovarian stimulation with gonadotrophins needing icsi for fertilizing oocytes. 2. availability of at least six mature oocytes (mii) after oocyte pick-up. 3. planned blastocyst culture. exclusion criteria: 1. intention to perform any form of preimplantation genetic testing 2. the use of imsi or polarized light in the icsi process 3. the use of assisted hatching prior to randomization. 4. surgical sperm retrieval (ssr) patients. 5. previous participation in this rct 6. concurrent participation in another investigation that can affect the primary outcome of this study. 7. sperm sample with \<0.1million/ml or motility of \<2% after preparation. 8. fertility preservation cycles. 9. if a day 2-4 transfer is planned 10. use of vitrified oocytes.

Keywords: icsi fertilization piezo-icsi oocyte blastocyst rate
the role of microrna-29b in the oral squamous cell carcinoma

Conditions: Oral Cancer

Summary: the role of microrna-29b in the oral squamous cell carcinoma

to find out if there is prognostic value which to the performance of microrna-29b of oral cancer in taiwan and provide some reference for future treatment. we anticipate to enroll 100 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period. we also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.

Eligibility criteria:
inclusion criteria: * cancer of the oral cavity. exclusion criteria: * pregnant woman * refuse the surgery

Keywords: microrna-29b oral squamous cell carcinoma migration prognosis
an investigator initiated trial to evaluate the safety and feasibility of the dynetic-35 stent for iliac lesions via a trans-radial approach

Conditions: Peripheral Arterial Disease

Summary: this feasibility study with a 30 day follow up period will assess the safety and feasibility of the dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.


Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years 2. subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the institutional review board (irb)/ethics committee (ec) of the respective clinical site prior to any study related procedure 3. subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements 4. subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries 5. target lesion is a de novo, restenotic or occluded lesion 6. reference lumen (vessel) diameter between 5mm and 10 mm 7. the target lesion can be successfully crossed with a guide wire 8. patient is eligible for transradial access 9. subject has symptomatic iliac artery disease defined as rutherford category 2 or higher exclusion criteria: 1. subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study. 2. subject is with a current medical condition with a life expectancy of less than one year. 3. pre-existing target iliac artery aneurysm or perforation or dissection 4. any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol 5. abdominal aortic aneurysm (aaa) contiguous to the iliac artery target lesion requiring treatment 6. the subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet 7. subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6f sheath 8. severe stenosis or calcification of upper extremity arteries 9. patient height precluding transradial access with a 170 cm long catheter shaft 10. patient with a history of aortic arch atheroembolism 11. infrainguinal outflow lesions that need to be treated during the same index procedure 12. patients with negative bilateral allen or barbeau tests (note: vascular access should be done via the left hand where possible) 13. subject has ifu listed contraindication(s) 14. subject has in-stent restenosis

Keywords: transradial access,
risk factors of incisional hernias after emergency midline laparotomy

Conditions: Incisional Hernia; Emergency Midline Laparotomy

Summary: the aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.

all patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is potential participants and will be screened for participation. potential participants will be briefly informed about the project by the hospital staff. if the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge. data will be obtained from the participants hospital files and by patient survey/interview. all data will be entered into a database using redcap by trial investigators or their delegates. enrolled patients will be followed for two years. the trial involves two clinical examinations and evaluations (one and two years) after surgery. clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.

Eligibility criteria:
inclusion criteria: * age of 18 years or above and * unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and crohn's disease), abscesses, non-traumatic intraabdominal bleeding and any emergency re-operation to elective surgery exclusion criteria: * age below 18 years * patients with mental or physical disorders making follow-up impossible * patients were no fascial closure is performed
prospective evaluation of the radiographic efficacy of enbrel

Conditions: Rheumatoid Arthritis; Psoriasis Arthritis

Summary: it is known from the comet-trial that patients who start enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. it is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of enbrel treatment (pre-treatment of at least 2 dmards, one of them mtx). therefore, no robust x-ray data are available to show/demonstrate * the average extent of x-ray damage in routine patients on enbrel outside clinical studies. * if the outstanding effect on structural damage of enbrel can be reproduced in routine practice. * that the 'silent progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making. * the optimal onset of enbrel treatment in the course of the disease to prevent radiographic damage

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study. * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study. subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * definitive diagnosis of ra or psa. * eligible for etanercept treatment according to summary of product characteristics (smpc). * inclusion of subjects pretreated with other biologics other than etanercept is possible * one plain radiograph of hands and feet (anteroposterior) within 3 month prior to initiation of treatment with etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to german recommendations for patients treated with biologics. exclusion criteria: * receipt of any investigational drug within 3 months of study inclusion. * exclusion criteria according to the enbrel® smpc, with particular attention to: * hypersensitivity to the active substance (etanercept) or to any of the excipients. * sepsis or risk of sepsis. * active infections, including chronic or localised infections. * subjects who have received any previous treatment with etanercept * subjects who are investigational site staff members or subjects who are pfizer employees directly involved in the conduct of the trial.
a comparison of extraperitoneal versus transperitoneal cesarean section

Conditions: Labor Pain

Summary: the aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.


Eligibility criteria:
inclusion criteria: * elective cesarean * previous cesarean (\<4) * cesarean for distocia exclusion criteria: * emergency cesarean ( fetal distress) * risk of obstetrical bleeding * maternal coagulation defects * adnexial mass * uterin myoma at incision site

Keywords: extra-peritoneal cesarean intra-peritoneal cesarean
a phase iii study of bms-188667 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.

this was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing designed study. the treatment period was 12 months. eligible participants were randomized to 1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's body weight; 500 mg for participants weighing \ 100 kg, monthly) or placebo intravenous (iv) infusion. all participants continued their background therapy(ies) for rheumatoid arthritis (ra) (non-biologic or biologic disease-modifying drugs \[dmards\], or combination) throughout the double-blind treatment period. double-blind study medication (abatacept or placebo) was administered on days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. all participants who completed the 12-month double-blind study period (day 1 through day 365), were eligible to continue into the open-label period. all eligible participants (active or placebo) were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mg/kg, based on their day 365 body weight. participants continued to receive infusions every 28 days.

Eligibility criteria:
inclusion criteria: * meet criteria of american rheumatism association for the diagnosis of rheumatoid arthritis and the american college of rheumatology functional classes i, ii iii or iv * participants must be taking 1 or more dmards and/or biologic approved for rheumatoid arthritis (ra) for at least 3 months and be on a stable dose for 28 days prior to day 1. exclusion: * other auto-immune disease as a main diagnosis (e.g. systemic lupus erythematosus \[sle\], scleroderma) * active tuberculosis (tb) requiring treatment within last 3 years
an open-label extension to evaluate the efficacy and safety of the rivastigmine transdermal patch in patients with probable alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable alzheimer's disease


Eligibility criteria:
inclusion criteria: * patients who fulfilled the inclusion and exclusion criteria as listed in the study cena713d2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Keywords: alzheimer's disease dementia
intraoperative cerebral and renal tissue oxygen saturation and pediatric living donor liver transplantation prognosis.

Conditions: Pediatric Liver Transplantation; Developmental Delay; Postoperative Complications; Socioemotional Delay

Summary: this rso2 study is a prospective clinical study. the purpose of the rso2 study is to investigate whether there is a correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay after living donor liver transplantation for children. this study will also investigate whether intraoperative cerebral and renal tissue oxygen saturation are related to postoperative complications.

there is high incidence of developmental and socioemotional delay and postoperative complications in pediatric living donor liver transplantation patients. in this prospective observational clinical study, the investigators aim to investigate the correlation between the intraoperative cerebral and renal tissue oxygen saturation and the incidence of developmental and socioemotional delay and postoperative complications. this study will enroll patients aged from 6 to 36 months old who are scheduled for elective standard living-donor liver transplantation and have signed informed consent before the surgery.

Eligibility criteria:
inclusion criteria: * pediatric patients (6 months\< the moon's age \<36 months) who will receive standard living-donor liver transplantation (ldlt) in renji hospital. exclusion criteria: * forehead skin infection, a history of liver transplantation, multivisceral transplantation, refused to participate the study